ASCO Participates in Workshop To Advance Anticancer Drug Development
A key component of quality cancer care is ensuring that cancer patients have access to effective therapies for the treatment of their disease. For this, we need a drug approval process that allows new agents to make their way to patients in a safe and expedient manner.
Last week, ASCO participated in a workshop with the U.S. Food and Drug Administration (FDA), the National Cancer Institute, the American Association for Cancer Research, academia, industry, and patient advocacy groups, to discuss measures to expedite the drug approval process. The workshop, "Accelerating Anticancer Agent Development and Validation," included more than 60 senior FDA officials who served as mentors, reviewed the regulatory requirements, and provided feedback for investigators on their drug testing strategies.
The primary goal of the workshop, according to Richard Pazdur, MD, Director of FDA’s Office of Oncology Drug Products, was to encourage translational research – transforming scientific discoveries into viable treatments for patients.
This type of collaborative meeting is important to providing the cancer care community with the information they need to ensure that lifesaving therapies are available to the patients who need them.
Congressional Movement on Healthcare Agenda
In the weeks leading up to Memorial Day recess, health care issues are at the forefront of Congress’s attention. Last week, the House and Senate considered a number of bills that address a variety of health care proposals, ranging from small business health plans to medical malpractice laws, health savings accounts to extending the Medicare drug plan sign-up date. As Congress advances its healthcare agenda, ASCO is communicating with members of Congress to highlight the need to advance quality cancer care legislation that:
- Ensures funding for cancer research and clinical trials.
- Continues to provide better access to treatments and services through quality initiatives.
- Provides coverage for long-term treatment planning and follow-up care for cancer patients.
- Ensures that the Medicare Modernization Act (MMA) provides access to necessary treatment regimens for all cancer patients on Medicare.
In addition, ASCO has worked with longtime cancer advocate, Rep. Ralph Hall (R-TX) to introduce HR 5179. This legislation would revise the Medicare system to ensure that critical chemotherapy drugs remain available to cancer patients by: (1) giving CMS the authority to increase drug payments when practices and institutions cannot obtain them for the Medicare payment rate, and (2) removing from the ASP formula prompt-pay discounts that are not passed on to practices and institutions, to better reflect the available market.
It is imperative that you ask your Representative in Congress to sign on as a co-sponsor of HR 5179. To find contact information for your representative, please visit ASCO’s Grassroots Action Center.
JOP Spotlight
This month’s issue of the
Journal of Oncology Practice (
JOP) features the Cancer Quality Alliance. Launched by ASCO and the National Coalition for Cancer Survivorship (NCCS) in 2005, the Cancer Quality Alliance is a forum created to improve the quality of care provided to people with cancer. The Alliance is fostering collaboration among stakeholders in the cancer care community to eliminate unnecessary duplication in cancer care quality efforts.
The article in JOP also highlights the Quality Oncology Practice Initiative (QOPI), a practice-based system of quality self-assessment. Currently, more than 100 practices are participating in QOPI to measure the extent to which they are adhering to quality-care guidelines.
This month’s JOP also features:
- A preview of the upcoming Annual Meeting in June.
- A continuing series sharing best practices on controlling drug expenses and diagnostic imaging.
- The kick-off of new series of articles to assist oncologists making career decisions and transitions.
- Information on National Institutes of Health (NIH) restructuring and the impact on the National Cancer Institute (NCI).
News and Notes
Upcoming ASCO National Audioconference
ASCO will hold a national audio-conference on May 24, to address the National Oncologic PET Registry (NOPR), Medicare Part D, and Competitive Acquisition Program (CAP). To register, dial 800-289-0579 and provide the 9113422 access code.
National Oncologic PET Registry
The National Oncologic PET Registry (NOPR) was developed in response to CMS' expanded coverage of FDG-PET scans. Medicare will cover FDG-PET scans when providers are participating in
and patients are enrolled in an approved FDG-PET registry. Providers will be required to submit patient and clinical data to the NOPR in order for the scan to be covered. Data will be reviewed and assessed to make ongoing coverage determinations regarding PET scans.
The NOPR opened May 8 and is now accepting patient entries. More detailed information on the registry is on the NOPR website at www.cancerpetregistry.org. Information also can be found on ASCO.org under the "MMA Regulations and Resources" heading. If you have any questions relating to the NOPR, please call Julia Tomkins at 703-299-1054.
ASCO’s Annual Meeting
Join us at ASCO’s premier Annual Meeting next month, June 2-6, in Atlanta, GA. This year’s theme is "Advocating Survivorship, Clinical Science, and Oncology Quality Care." The "Practice Management and Professional Issues" track will highlight reimbursement and quality care issues. For more detailed information, search ASCO’s 2006 Online Pocket Program.
